MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-08 for NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM ABI24M manufactured by Cochlear Ltd ..
[25097964]
Device is currently unavailable.
Patient Sequence No: 1, Text Type: N, H10
[25097965]
Per the clinic, the device was explanted on (b)(6) 2015 due to tumor resection necessary for multiple large tumors. During the same procedure the patient was re-implanted with a new device. The device has not been made available for analysis as of the date of this report, (b)(4) 2015.
Patient Sequence No: 1, Text Type: D, B5
[48406404]
Correction: the correct common device name is mhe, not mcm as previously reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2015-01807 |
| MDR Report Key | 5059806 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-08 |
| Date of Report | 2016-01-29 |
| Date of Event | 2015-08-10 |
| Date Mfgr Received | 2015-08-13 |
| Date Added to Maude | 2015-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE HILLE |
| Manufacturer Street | 13059 EAST PEAKVIEW AVENUE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 3037909010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic Name | MHE, PRODUCT CODE: |
| Product Code | MHE |
| Date Received | 2015-09-08 |
| Returned To Mfg | 2015-10-07 |
| Model Number | ABI24M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD . |
| Manufacturer Address | 14 MARS RD PO BOX 629 LANE COVE, NSW 2066 AS 2066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-08 |